Modelling and Informatics Challenges IN Film-BASED Drug Formulations and Manufacture

Drug-loaded thin films are a novel pharmaceutical administration form that is creating an increasing interest in the pharmaceutical industry due to its versatility of application and the feasibility of continuous manufacture. However, accomplishing this in industrial scale requires addressing the modeling and informatics challenges that arise in going from concept to reality. One has to deal with wide ranging data, information and models from pre-formulation studies, product formulation, process development, and manufacturing. We plan to address these challenges by first designing an appropriate ontological informatics framework for describing the whole film casting manufacture process. The film manufacture process consists of three main steps: (1) Synthesis of sub-micron engineered particles (2) Particle-loaded polymeric suspension formulation and preparation (3) Thin-film casting Particle-loaded polymeric suspension preparation and thin film casting are assessed employing a response surface experimental design. The study correlated formulation parameters like particle load, solvent composition or plasticizer amount and processing parameters like drying temperature or wet film thickness over a range of properties interesting from a processing and a formulation point of view. The statistical results obtained from this experimental design are useful for: (1) Gaining a deeper understanding in the effect of processing conditions in drug loaded film manufacture (2) Provide formulators with tools that will enable them to formulate films with the desired final properties (3) Obtain simple descriptive models that could be applied later on process control. With the information obtained from experiments and process description, an appropriate ontological informatics framework was designed by exploiting our prior contributions in this area, namely, the Purdue Ontology for Pharmaceutical Engineering (POPE). We will report on the details of this framework, the integration of diverse sources of information ranging from process control applications to product characterization or film formulation models and guidelines, as well as lessons learnt from the implementation of the experimental testbed in drug loaded films manufacture